BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C2 CRYOBALLOON ABLATION SYSTEM

    MDR report key: 6361363 · Received February 27, 2017

    Report

    Report Number
    3008780134-2017-00003
    Event Type
    Injury
    Date Received
    February 27, 2017
    Date of Event
    January 20, 2017
    Report Date
    February 27, 2017
    Manufacturer
    C2 THERAPEUTICS, INC.
    Product Code
    GEH
    UDI-DI
    00854924006095
    PMA / PMN Number
    K161202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND COULD NOT BE FURTHER INVESTIGATED. BASED ON THE INFORMATION REPORTED FROM THE PHYSICIAN, THE DEVICE APPEARS TO HAVE FUNCTIONED AS INTENDED.

    Description of Event or Problem · 1

    DURING THE (B)(6) 2016 PROCEDURE, 11 ABLATIONS WERE PERFORMED. THE PATIENT REPORTED A PAIN SCORE OF 4 (1 TO 10 SCALE) ON DAY 1 AND 0 ON DAY 7. ON (B)(6) 2017, THE PATIENT CAME TO THE EMERGENCY ROOM WITH DIFFICULTY SWALLOWING FOR 3 DAYS. AN ENDOSCOPY WAS PERFORMED AND SHOWED A BENIGN APPEARING ESOPHAGEAL STENOSIS THAT WAS DILATED. THE PATIENT'S SYMPTOMS IMPROVED, BUT HE WAS UNABLE TO CONSUME A NORMAL DIET THROUGH 4 DAYS POST DILATION. AN ENDOSCOPY WAS PERFORMED ON (B)(6) 2017. THERE WAS A SEVERE BENIGN STENOSIS. THE STRICTURE HAD A 6 MM DIAMETER AND 1 CM LENGTH. COAGULATION FOR TISSUE DESTRUCTION USING A MONOPOLAR PROBE (IT2 KNIFE) WAS PERFORMED. DILATION WITH A 15-16.5-18 MM X 5.5 CM CRE BALLOON DILATOR WAS PERFORMED TO 16 MM, AND THE AREA WAS INJECTED WITH 80 MG OF TRIAMCINOLONE (40 MG/ML, DILUTED UP TO 5 ML). THE STOMACH AND DUODENUM WERE NORMAL. THE PATIENT IS SCHEDULED FOR REPEAT UPPER ENDOSCOPY IN 1 MONTH FOR RETREATMENT. THE PHYSICIAN STATED THAT, "THE STRICTURES WILL OCCUR AFTER ANY MUCOSAL ABLATING THERAPY, THIS EVENT IS NOT LIFE-THREATENING AND AS SUCH I WOULD LIKE TO WAIT AND SEE THE COMPLETE UPDATE IN 2 WEEKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144040 C2 CRYOBALLOON ABLATION SYSTEM CRYOSURGICAL UNIT WITH ACCESSORIES GEH C2 THERAPEUTICS, INC. FG-1009, FG-1012 06092016-01 00854924006095

    Patients

    Seq Age Sex Outcome Treatment
    1 Other