BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C2 CRYOBALLOON FOCAL ABLATION SYSTEM

    MDR report key: 5909276 · Received August 26, 2016

    Report

    Report Number
    3008780134-2016-00011
    Event Type
    Injury
    Date Received
    August 26, 2016
    Report Date
    August 23, 2016
    Manufacturer
    C2 THERAPEUTICS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K131523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS NOT RETURNED FOR EVALUATION. FOR THE DEVICE ANALYSIS, THE DATA FROM THE CONTROLLER WAS DOWNLOADED AND ANALYZED. THE DATA SHOWS A SINGLE PRE-TREATMENT INFLATION; PEAK BALLOON PRESSURE WAS 2.6 PSIG. THE DATA IS CONSISTENT WITH THE COMPLAINT NARRATIVE REGARDING DEVICE USE. THE CONTROLLER WAS FUNCTIONALLY TESTED. NO ISSUES WERE IDENTIFIED, AND THE DEVICE WAS FOUND TO OPERATE WITHIN SPECIFICATIONS. THE ROOT CAUSE OF THE CUSTOMER'S OBSERVATION WAS UNABLE TO BE DETERMINED FROM THE DEVICE ANALYSIS AND DID NOT APPEAR TO BE RELATED TO ANY DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THE PATIENT IN HER (B)(6) WAS TO BE TREATED FOR A SMALL RESIDUAL PATCH OF SQUAMOUS DYSPLASIA OF A RAISED AREA FOLLOWING EMR ABOUT 6 MONTHS PREVIOUSLY. THE ENDOSCOPE WAS INSERTED INTO THE OESOPHAGUS, AND THE SMALL PATCH WAS LOCATED AT AROUND 35CM. THE AREA WAS THEN WASHED WITH 1% LUGOL'S SOLUTION TO CHECK / CONFIRM THE AREA TO BE ABLATED. THE CATHETER WAS INTRODUCED INTO THE SCOPE AND THE BALLOON POSITIONED CORRECTLY ALONGSIDE THE AREA TO BE ABLATED. AROUND 5-10 MINUTES ELAPSED SINCE THE LUGOL'S HAD BEEN USED. THE BALLOON WAS INFLATED USING THE CARTRIDGE IN THE CONTROLLER, AND SOME BLOOD WAS OBSERVED IN THE OESOPHAGUS. THE BALLOON WAS DEFLATED BY SYRINGE, AND THE OESOPHAGUS INSPECTED, UPON WHICH BLOOD ON THE LESION OPPOSITE AND SLIGHTLY DISTAL TO THE TARGETED TREATMENT AREA WAS NOTED. THE DOCTOR DIAGNOSED IT AS A SHORT LACERATION AND WAS UNSURE IF IT HAD PERFORATED. THE ENDOSCOPE WAS IMMEDIATELY WITHDRAWN AND THE PATIENT INSPECTED FOR ANY ISSUES. THE PATIENT WAS SENT FOR A CT SCAN, WHICH CONFIRMED THAT IT HAD PERFORATED. THE PATIENT WAS HOSPITALIZED FOR FURTHER ASSESSMENT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2016. THE PATIENT WAS DISCHARGED AFTER HAVING RESOLVED WELL IN HOSPITAL. AT DISCHARGE SHE WAS DIAGNOSED BY CT AS HAVING HAD A SMALL PERFORATION WHICH HEALED NORMALLY WITHOUT HAVING TO USE A CLIP OR STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561080 C2 CRYOBALLOON FOCAL ABLATION SYSTEM CRYOSURGICAL UNIT WITH ACCESSORIES GEH C2 THERAPEUTICS, INC. FG1012, FG1009

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization