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U.S. Department of Health and Human Services

Class 2 Device Recall C2 CryoBalloon Ablation System

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  Class 2 Device Recall C2 CryoBalloon Ablation System see related information
Date Initiated by Firm December 03, 2018
Create Date March 01, 2019
Recall Status1 Terminated 3 on August 21, 2020
Recall Number Z-0970-2019
Recall Event ID 81695
510(K)Number K163684  
Product Classification Unit, cryosurgical, accessories - Product Code GEH
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.
Code Information All lot numbers
Recalling Firm/
Manufacturer		 PENTAX of America Inc
303 Convention Way
Ste 1
Redwood City CA 94063-1465
For Additional Information Contact
650-521-5304
Manufacturer 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.
FDA Determined
Cause 2		 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 customeradvisories@pentaxmedical.com, 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEH and Original Applicant = C2 Therapeutics, Inc.
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