BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOBALLOON FOCAL ABLATION SYSTEM

    MDR report key: 6361297 · Received February 27, 2017

    Report

    Report Number
    3008780134-2016-00003
    Event Type
    Injury
    Date Received
    February 27, 2017
    Date of Event
    March 14, 2016
    Report Date
    April 1, 2016
    Manufacturer
    C2 THERAPEUTICS, INC
    Product Code
    GEH
    PMA / PMN Number
    K131523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATA FROM THE CONTROLLER WAS DOWNLOADED AND REVIEWED. THE DATA SHOWS 12 COMPLETE 10-SECOND TREATMENTS FOLLOWED BY 1 PARTIAL TREATMENT WHICH TERMINATED DUE TO MANUAL RELEASE OF THE TRIGGER. AS THE ONLY SIGNIFICANT TREATMENT ATTRIBUTE THAT COULD BE RELATED TO THE DEVELOPMENT OF STRICTURE THAT THE CONTROLLER REGULATES IS TIME, THE ACCURACY OF THE CONTROLLER TIME KEEPING FUNCTION WAS VERIFIED. THE CONTROLLER WAS TURNED ON AND THEN THE "ON TIME" VALUE WAS REQUESTED BY THE COMPUTER INTERFACE AT THE SAME TIME A STOPWATCH WAS STARTED. AFTER 120 SECONDS HAD ELAPSED ON THE STOPWATCH, THE "ONTIME" VALUE WAS AGAIN REQUESTED. THE DIFFERENCE BETWEEN THESE VALUES WAS 1191, WHICH IS 119.1 SECONDS. THIS INDICATES THAT THE TIMEKEEPING FUNCTION IS ACCURATE TO 0.8% AND THEREFORE WITHIN THE SPECIFIED MANUFACTURING TOLERANCE OF ± 2.0%. BASED ON THE DATA, THERE DOES NOT APPEAR TO BE ANY CONTROLLER MALFUNCTIONS THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    (B)(6) MALE WITH HGD - HIGH GRADE DYSPLASIA HAD UNEXPLAINED WEIGHT LOSS, WAS SEEN AT (B)(6) CLINIC FOR A CARDIAC PROCEDURE, WHICH INVOLVED AN ENDOSCOPY (EDG) AND CAUSED A TEAR IN THE ESOPHAGUS. ON (B)(6) 2016 - INITIAL CRYOBALLOON, TORTUOUS ESOPHAGUS (UNKNOWN HOW MANY CRYOBALLOON ABLATIONS WERE INVOLVED). POST ABLATION REQUIRED NARCOTICS. HIS DIET ADVANCED AND STARTING (B)(6), HAD TROUBLE SWALLOWING WATER. ON (B)(6) 2016 - REPORTED STRICTURE. HE IS ADMITTED TO HOSPITAL - NO PAIN AND IS HAVING A FEEDING TUBE PLACED. ADDITIONAL INFORMATION RECEIVED ON 18 APRIL, 2016 FROM DOCTOR CANTO VIA COMPANY REPRESENTATIVE: THE PATIENT IS DOING MUCH BETTER. HE WAS DILATED. HE'S EATING SOFT FOODS AND WILL GET THE FEEDING TUBE REMOVED SOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142989 CRYOBALLOON FOCAL ABLATION SYSTEM CRYOSURGICAL UNIT, CRYOGENIC SURGICAL DEVICE GEH C2 THERAPEUTICS, INC FG 1012 01282016-01

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R