MAUDE Adverse Event Report: C2 THERAPEUTICS CRYOBALLOON FOCAL ABLATION SYSTEM; CRYOSURGICAL UNIT AND ACCESSORIES.

Model Number	FG-1017
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
International medical device regulators forum (imdrf) adverse event reporting.Health effect clinical code: (b)(4) no clinical signs, symptoms or conditions.Health effect impact code: (b)(4) no health consequences, or impact.Medical device problem code: (b)(4) gas output problem.
Event or Problem Description
Pentax medical was made aware of a complaint that occurred in the operating room during use in the united states.The reported complaint that the physician had pressed and released the nitrous oxide delivery switch, but the product continued to deliver nitrous oxide until the end of a full treatment cycle.The controller displayed a non-standard screen.The screen was non-responsive, and the controller made a continuous tone until the power/communication cord for the controller was disconnected and reconnected, involving pentax medical c2 cryo-balloon golf controller, model: fg-1017, lot number 0243.At the time of reporting, the pentax medical director of engineering for c2 products documented that a serious injury occurred, but no additional detail was provided at the time.The pentax medical director of engineering for c2 products responded to a good faith effort request for additional information via email on 22-oct-2020, and stated the cryo-balloon ablation system was being used for patient treatment.The serious injury was a single unintended treatment of tissue, although no patient harm was noted.This momentary delay resulting in a few seconds of extra anesthesia.The patient was not recalled for further screening, and was released from the hospital.The user completed the procedure with the controller and notified pentax medical of the malfunction.The user facility does follow pre-inspectional checks, and all product and accessory instructions for use.The returned controller will be evaluated as part of the investigation.Investigation is in-process.

• Brand Name: CRYOBALLOON FOCAL ABLATION SYSTEM
• Common Device Name: CRYOSURGICAL UNIT AND ACCESSORIES.
• Manufacturer (Section D): C2 THERAPEUTICS; 303 convention way; redwood city CA 90463
• MDR Report Key: 10805342
• Report Number: 3008780134-2020-00006
• Device Sequence Number: 3680836
• Product Code: GEH
• UDI-Device Identifier: 00854924006170
• UDI-Public: 00854924006170
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K190194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FG-1017
• Device Catalogue Number: FG-1017
• Device Lot Number: 0243
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other