Z-0970-2019Class II

C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation...

Name: Z-0970-2019 C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation...
Creator: PENTAX of America Inc
Published: 2018-12-03
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2018-12-03 / Terminated / root cause: manufacturing process

FDA source

PENTAX of America Inc began a recall of C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in... on 2018-12-03. FDA classified it as Class II and gives the reason as "The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen of the catheter is...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0970-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-03
Posted: 2019-03-01
Terminated: 2020-08-21
Recalling firm: PENTAX of America, Inc.
Product: C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus.
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen of the catheter is significantly occluded to prevent relieving balloon pressure due to a kinked catheter condition.If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 10/18/18, the firm, Pentax Medical, started contacting US Affected Customers by telephone to inform them of the pending action and to advise they discontinue use and quarantine affected devices. On 12/03/18, "URGENT MEDICAL DEVICE REMOVAL" letters dated 11/16/18 were mailed via USPS Certified Mail to its customers. Customer response forms and Customer Return Material Shipment Labels were mailed with the removal notices. Customers were informed that affected products should not be used and should be returned to the firm. In addition, customers were asked to ensure that all potential users in their facilities are made aware of the removal notice and the recommended actions. Customers were asked to complete and return the Field Action Response Form via: Fax to PENTAX Recall Coordinator at 201-799-4063 (alternate 201-391-4189) or Email a pdf copy to [email protected], or mail with the returned affected product to:Pentax of America Inc,,303 Convention Way Suite 1, Redwood City, CA 94063, Attention: 2018-009-R Action. . Customers with additional questions were encouraged to call 650-318-5899 (8:30 AM - 5:00 PM, Monday - Friday, PST).
Quantity in commerce: 45
Distribution: Worldwide Distribution: US (nationwide) to states of:: CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA;; and countries: Canada, Germany, and Netherlands.
Product codes and lots: All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0970-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0970-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-13	2019-03-01

Product code GEH

K163684Class IIC2 CryoBalloon Ablation SystemC2 Therapeutics, Inc. / cleared 2018-01-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)